PMDA-ATC & U.S. FDA Pediatric Review Seminar 2018

Introduction

The addendum to ICH E11 entitled, Clinical investigation on medicinal products in the pediatric population (E11), issued as Step 4 in 2017, highlights the recent advances in scientific and technical knowledge in pediatric medicinal product development. To further disseminate information on pediatric drug development (as part of medicinal product development), the Food and Drug Administration of the United States (U.S. FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan are pleased to announce the joint “PMDA-ATC & U.S. FDA Pediatric Review Seminar 2018” at the PMDA Office in Tokyo on June 11-14, 2018. This seminar is intended for regulatory authority officials who are engaged in the review of pediatric drug development programs.

The seminar will cover current pediatric guidelines and practices in the United States and Japan, and will provide the opportunity for the participants to share current pediatric guidelines and practices in their respective countries and regions. Case study sessions on pediatric drug development programs are also planned for small group discussions among the participants.

The aim of the seminar is to provide opportunities for the participants to review their own programs and to gather additional information that may enhance the review of pediatric drug development programs within their own regulatory frameworks.

The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
The training will be provided in English (with consecutive translation in some sessions).
All participants are expected to actively participate in all of the sessions.

Key Seminar Objective

By participating in this seminar, the participants will understand:

Scientific, ethical and regulatory considerations when evaluating drug products being developed for the pediatric population

Globally standard guidelines relating to the review of drug products being developed for the pediatric population, e.g., ICH guidelines

Current practice and issues in the review of drug products being developed for the pediatric population when data are collected in adults and the pediatric population of other races.

Who should apply

Employees of regulatory authority with working experience in pediatric field for over 3 years.

Date

June 11 to 14, 2018

Program (subject to change)

Participating regulatory authorities may request individual meetings with PMDA and FDA. These meetings will allow participating agencies to ask specific questions related to their agencies. Each meeting will be 30 minutes.

Registration (Registration is closed.)

Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached). Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.

Registration was closed on March 30, 2018.

Early registration is recommended. The registration may close before the deadline depending on the number of applications. Also, please be sure to allow enough time to obtain the visa for entry to Japan.

If the number of applications exceeds the capacity, the number of participants from each country may be limited.

Confirmation of the registration and additional information will be sent to the approved participants after the close of registration.

Please indicate if your agency would like to have an individual meeting with PMDA and FDA.

Fee

There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.